Quality Assurance Associate I at SPR – Cleveland, Ohio

Responsible for working with Quality Assurance, Regulatory Affairs, Engineering, Manufacturing, and other company personnel to perform Quality Assurance activities.

Works with the team to ensure continued compliance with ISO 13485 and FDA’s Quality Standard Regulation (21 CFR 820).

RESPONSIBILITIES

1. Assist the Field Report Coordinator in the processing of product complaints, including receipt of information from field personnel, completion of reportability decision trees, completion of risk assessments, and review of build documentation.
2. Coordination of product returns associated with product complaints, expiring, and unused product.
3. Assist with the supplier qualification and monitoring program.
4. Support internal and external audits.
5. Support periodic management review of quality metrics.
6. Perform incoming, in-process and final inspections according to schedule.

ADDITIONAL RESPONSIBILITIES

1. Perform document control activities.
2. Initiate and own nonconformances and track activities to closure.
3. Attend conferences and seminars to understand and extend company awareness of up-to-date activities in the Quality Assurance field.
4. Performs other duties and projects as assigned by management.

KNOWLEDGE AND SKILL REQUIREMENTS

Experience, Competencies, Education:

• Bachelor’s or Associate’s degree in Quality Assurance, Technology, Engineering, Manufacturing, Science and/or another technical program with additional relevant medical device quality systems experience.
• 0-2 years of experience in medical device quality assurance.
• Strong self-starter, effective team player, data driven, and detail-oriented.
• Proficient with MS Office.
• An effective oral and written communicator and be able to lead meetings and clearly present ideas.

Beneficial Skills and Experience:

• Understanding of US medical device regulatory compliance requirements (ISO 13485 and FDA’s QSR).
• Experience in neurostimulation products.

WORKING CONDITIONS

• Ability and willingness to “get the job done”, allowing for flexible and extended hours, depending upon the project needs
• Small office environment (does own documentation and interacts directly with others in virtually all situations)
• Travel will be minimal, and when necessary, can usually be well planned in advance (examples include industry trade meetings, technical training, visits to key supplier sites, etc.)